Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 18 December 2025 has been entered.
Claim Status
Applicant’s Remarks and Amendments filed 18 December 2025 have been entered. Claims 1-8 are pending.
Response to Arguments
Applicant’s arguments with respect to the objection of claim 1 are persuasive. The objection of claim 1 is withdrawn.
Applicant's arguments filed 18 December 2025 have been fully considered but they are not persuasive. Regarding Applicant’s arguments that Gwak, Kennedy, and Xu fail to teach the surgical method of the claims and one of ordinary skill in the art would not have had a reasonable expectation of success in arriving at the claimed surgical method from their combined teachings (pg. 4-5 of remarks), Examiner respectfully disagrees. Applicant’s assertion that “cylindrical dissection does not refer to a simple cylindrical shape of dissection, but rather means removing the tumor along with a sufficient safety margin to prevent local recurrence” (pg. 5 of remarks) is understood, however this definition does not translate to the claims as they are stated, nor is present in Applicant’s specification to provide a further definition to the “cylindrical” removal claimed. The only time “cylindrical” is stated in Applicant’s current specification is with regard to the “cylindrical cavity” formed for the dADM volume replacement which under the broadest reasonable interpretation, Examiner understands to mean that the excised tumor cavity merely needs to be cylindrical in shape. Regardless, Kennedy teaches that the cannula and cutter chosen by the surgeon are of a sufficient size to form a negative margin around the tumor to satisfy the surgeon and pathologist of full tumor removal [0034-0036] similar to Applicant’s definition given in the arguments. The current state of the claims and specification provides no insight into Applicant’s intended meaning of “cylindrical dissection” and therefore cannot be considered by Examiner.
Regarding Applicant’s argument that there is “no teaching, suggestion, or motivation in the combination of Gwak, Kennedy, and Xu to arrive at the claimed method” because “none of the combination of cited references teach or suggest removing a breast tumor upwards cylindrically” (pg. 8 of remarks), Examiner respectfully disagrees. As previously stated in the Office Action dated 26 September 2025, and Applicant’s remarks dated 18 December 2025, Kennedy admittedly fails to teach “upward” removal of a tumor. However, Kennedy teaches the device and process disclosed is desirable for both the patient and the surgeon for more reliably and expediently removing tumors from the body and provides the ability to reexcise the initial excision cavity to form clear negative margins of tissue [0007]. Applicant’s argument that Kennedy only teaches cutting “downwardly” appears rather narrow, when it seems to Examiner that Kennedy is merely teaching “press[ing]” [0036] the device into the tissue in order to begin excision of the tumor (“the cutter and cannula are pressed into the tissue of the patient with the expectation that the circular core of breast tissue formed by the cutter will have clear margins about the tumor” (abstract)). The device taught by Kennedy is therefore applicable to be combined with Gwak and Xu because it is capable of cutting into the breast tissue, at any location on the breast, and excising a tumor, similar to Applicant’s claims.
Further, Applicant’s arguments that Xu fails to teach or suggest “removing the breast tumor upwards cylindrically from the bottom of the breast parenchyme to a subcutaneous fat layer with a retromammary approach through a transaxillary or inframammary fold route, wherein the retromammary approach is performed through a transaxillary or intramammary fold incision to enter the retromammary space from the lateral or inferior side of the pectoralis muscle through the incision” (pg. 9 of remarks), Examiner respectfully disagrees. Understanding the claim under its broadest reasonable interpretation, Examiner interprets this portion of the claim to mean the surgical method has two options of approach into the retromammary space: the first being from the transaxillary incision near the armpit and therefore from the side of the pectoralis muscle, and the second being approaching the mammary space from the underside of the breast, through the inframammary fold incision and therefore from the inferior side of the pectoralis muscle. Applicant’s specification defines the retromammary space as the “working space between pectoralis major muscles and the lowermost bottom surface of breast” (pg. 6-7 of Specification). Xu teaches a surgical procedure that begins with “a probe…inserted into the posterior of the tumor via the retromammary spaces under ultrasonic guidance” and that the “probe aperture was turned facing up towards the tumor” in order to biopsy the tumor after rotation of the probe (pg. 2, par. 3). Further, Xu teaches that the “dissected tumor and axillary specimen were extracted through the axillary incision” (pg. 2, par. 4). Therefore, Xu teaches a retromammary approach through a transaxillary…incision to enter the retromammary space from the lateral…side of the pectoralis muscle through the incision as recited in claim 1. Xu also teaches that endoscopy-assisted techniques for the removal of malignant tumors have been described previously with better cosmetic outcome than the conventional BCS, and in Mammotome-assisted endoscopic BCS, the surgeon can accurately dissect the tumor margin and free the tumor under real-time ultrasonic guidance (pg. 5, par. 1) which is similar to Kennedy’s teaching of “the use of an ultrasound instrument with the cannula and cutter…for reading the position of the tumor…and therefore accurately position the cannula and cutter in alignment with the tumor [0012]. Therefore there is reasoning to combine Gwak, Kennedy, and Xu to teach Applicant’s claims, and the claims stand rejected.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Gwak et al., “Volume replacement with diced acellular dermal matrix in oncoplastic breast-conserving surgery: a prospective single-center experience.”, “Gwak”, in view of Kennedy (US 2009/0125035 A1), “Kennedy”, and further in view of Xu et al., “Mammotome-assisted endoscopic breast-conserving surgery: a novel technique for early-stage breast cancer”, “Xu”.
Regarding claim 1, Gwak teaches a surgical method for breast reconstruction (abstract), comprising: removing a breast tumor by conducting breast-conserving surgery (BCS) (study comprises 120 traditional BCSs (breast-conserving surgery) (pg. 6, par. 2)) and filling a defect from which the breast tumor is removed with a diced acellular dermal matrix (dADM) (volume replacement) (Fig. 3, excision cavity is filled with dADM pieces (pg. 2, par. 7)), but fails to teach removing the breast tumor upwards cylindrically from the bottom of the breast parenchyme up to a subcutaneous fat layer with a retromammary approach through a transaxiallary or inframammary fold route; and wherein the retromammary approach is performed through a transaxiallary or inframammary fold incision to enter the retromammary space from the lateral or inferior side of the pectoralis muscle through the incision.
Kennedy teaches a surgical cutting instrument comprising removing the tumor cylindrically (Fig. 2, cutter 14 is cylindrical in shape and yields cylindrical core 60 of excised tissue [0033-0034]). Kennedy discloses that the device yields a cavity in the breast that is cylindrical which improves cosmetic results [0035]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the surgical method and diced acellular dermal matrix taught by Gwak with the cylindrical removal method taught by Kennedy in order to improve cosmetic outcomes for the patient. However, Gwak in view of Kennedy fails to teach removing the tumor upwards from the bottom to subcutaneous fat layer with a retromammary approach through a transaxiallary or inframammary fold route and a breast-conserving oncoplastic technique wherein the retromammary approach is performed through a transaxillary or inframammary fold incision to enter the retromammary space from the lateral or inferior side of the pectoralis major muscle through the incision site.
Xu teaches an endoscopic breast-conserving surgery comprising removing the tumor upwards from the bottom of the breast parenchyme up to subcutaneous fat layer with a retromammary approach (Fig. 1, a probe…inserted into the posterior of the tumor via the retromammary spaces under ultrasonic guidance (pg. 2, par. 3)) through a transaxiallary or inframammary fold route (Fig. 1, (A) dissected tumor and axillary specimen were extracted through the axillary incision (pg. 2, par. 4)) and wherein the retromammary approach is performed through a transaxillary or inframammary fold incision to enter the retromammary space from the lateral or inferior side of the pectoralis major muscle through the incision site (Figs. 1-2, a probe…inserted into the posterior of the tumor via the retromammary spaces under ultrasonic guidance” and that the “probe aperture was turned facing up towards the tumor (pg. 2-3)). Xu discloses that this surgical approach could provide a significantly better cosmetic outcome than conventional lumpectomy (pg. 5, par. 2). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the diced acellular dermal matrix taught by Gwak with the cylindrical removal method taught by Kennedy and the lateral retromammary approach taught by Xu in order to have the best cosmetic outcome.
Regarding claim 3, Gwak teaches wherein the diced acellular dermal matrix is filled through the incision right after removing the breast tumor (Fig. 3, excision cavity is filled with dADM pieces (pg. 2, par. 7)) with safety margins during the breast-conserving surgery (Fig. 3, mass obtained a negative tumor margin once excised and is subsequently filled with diced ADM pieces (pg. 2, par. 6)), but Gwak in view of Kennedy fails to teach the transaxillary or inframammary fold incision.
Xu teaches an endoscopic breast-conserving surgery comprising the transaxillary or inframammary fold incision (Figs. 1-2 depict mammotome-assisted endoscopic breast conserving surgery techniques comprising endoscopic lateral approaches from the subcutaneous and retromammary spaces (pg. 2-3)). Xu discloses that this surgical approach could provide a significantly better cosmetic outcome than conventional lumpectomy (pg. 5, par. 2). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the diced acellular dermal matrix taught by Gwak with the cylindrical removal method taught by Kennedy and the lateral retromammary approach taught by Xu in order to have the best cosmetic outcome.
Regarding claim 4, Gwak teaches wherein the diced acellular dermal matrix has an average diameter of 3 to 10 mm (diced human acellular dermal matrix measuring 3-5 mm was used (pg. 1, methods)).
Regarding claim 5, Gwak teaches wherein the diced acellular dermal matrix is a cube having a side length of 3 to 7 mm (Fig. 2, diced human acellular dermal matrix are cubes and measure 3-5 mm (pg. 1, methods)).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Gwak et al., “Volume replacement with diced acellular dermal matrix in oncoplastic breast-conserving surgery: a prospective single-center experience.”, in view of Kennedy (US 2009/0125035 A1), “Kennedy”, and Xu et al., “Mammotome-assisted endoscopic breast-conserving surgery: a novel technique for early-stage breast cancer”, “Xu” and further in view of Griffey et al. (US Pat. No. 6933326 B1), “Griffey”.
Regarding claim 6, Gwak teaches wherein the diced acellular dermal matrix is prepared by removing an epidermal layer and cells from human skin tissue (ADM is derived from donated human skin which has its epidermal and dermal cells removed (pg. 2, par. 6). Gwak in view of Kennedy and Xu fails to teach granulating skin tissue from which the epidermal layer and cells are removed.
Griffey teaches a particulate acellular tissue matrix having a fibrous acellular dermal matrix comprising granulating skin tissue from which the epidermal layer and cells are removed (Fig. 1, during preparation of a particulate acellular tissue matrix a homogenizer is activated to fracture the matrix into various particles sizes (cols. 6-8, Preparation of Particulate Acellular Matrix)). Griffey discloses that the formation process of the acellular matrix utilizes a chemical free and minimally disruptive technique that minimizes damage to the collagen fibers (col. 3, lines 46-48). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the dADM formulation methods taught by Gwak with the ADM formulation methods taught by Griffey in order to limit damage to the collagen fibers of the sample skin.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Gwak et al., “Volume replacement with diced acellular dermal matrix in oncoplastic breast-conserving surgery: a prospective single-center experience.”, “Gwak”, in view of Kennedy (US 2009/0125035 A1), “Kennedy”, and Xu et al., “Mammotome-assisted endoscopic breast-conserving surgery: a novel technique for early-stage breast cancer”, “Xu” and further in view of Kim et al. (CN 114190075 A), “Kim”.
Regarding claim 7, Gwak in view of Kennedy and Xu fails to teach the limitations of claim 7. However, Kim teaches a method for producing acellular skin material wherein the removal of an epidermal layer and cells from the skin tissue is performed using a decellularization solution [0056-0057], and the decellularization solution is one or more selected from the group consisting of sodium hydroxide, potassium hydroxide, ammonium hydroxide, calcium carbonate, magnesium hydroxide, calcium hydroxide and ammonia (decellularization is carried out using one of sodium hydroxide, potassium hydroxide, ammonium hydroxide, calcium carbonate, magnesium hydroxide, calcium hydroxide and ammonia [0057]). Kim discloses that by using the decellularization solutions listed above there is no damage caused to the dermis itself and no toxicity [0057]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the surgical method and dADM taught by Gwak with the decellularization solutions taught by Kim in order to avoid damage to the dADM during its formation.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Gwak et al., “Volume replacement with diced acellular dermal matrix in oncoplastic breast-conserving surgery: a prospective single-center experience.”, “Gwak”, in view of Kennedy (US 2009/0125035 A1), “Kennedy”, and Xu et al., “Mammotome-assisted endoscopic breast-conserving surgery: a novel technique for early-stage breast cancer”, “Xu” and further in view of An et al., “The Comparison of Breast Reconstruction Using Two Types of Acellular Dermal Matrix after Breast-Conserving Surgery.”, “An”.
Regarding claim 8, Gwak teaches filling with the diced acellular dermal matrix (Fig. 3, excision cavity is filled with dADM pieces). Gwak in view of Kennedy and Xu fails to teach performing radiation therapy afterward.
An teaches breast conserving surgery methods using different acellular matrices involving performing radiation therapy after breast conserving surgery (BCS with subsequent radiation therapy has been developed and shows a similar outcome to mastectomy (An et al., par. 8)). An discloses that BCS with radiation treatment preserves the original breast shape and the surgery can be performed faster than a mastectomy (An et al., par. 8). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the step of radiation therapy after filling the surgical site with dADM in order to best preserve the original breast shape.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIELLA GISELLE B RIOS whose telephone number is (703)756-5958. The examiner can normally be reached M-Th 7:30-6:00 EST.
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/G.G.R./ /THOMAS C BARRETT/Examiner, Art Unit 3774 SPE, Art Unit 3799